This section provides background information related to the present disclosure which is not necessarily prior art.
Adhesion barriers, for example SEPRAFILM®, available from Genzyme Corporation, are placed between injured tissues or organs during surgery to separate the tissues and organs while they heal. See, for example, U.S. Pat. No. 5,527,893, the disclosure of which is incorporated herein by reference. These barriers keep the tissues and organs separated until they heal and develop natural protection against the formation of adhesions, and then the film is simply absorbed and eliminated naturally by the body. SEPRAFILM®, products are transparent films that are designed to act as a temporary barrier between tissue layers during the early days of tissue healing, thereby reducing adhesion formation. More specifically, SEPRAFILM® products are sterile bioresorbable transparent adhesion barriers composed of two anionic polysaccharides, namely sodium hyaluronate and carboxymethylcellulose. Together, these two biopolymers are chemically modified with an activating agent 1-(3-dimethylaminopropyl)-3-ethylcarbodimide hydrochloride. SEPRAFILM® products hydrate to a gel within 24 48 hours following placement in the body and then slowly resorb from the abdominal cavity in about five days.
According to the package insert, SEPRAFILM® products are placed at a desired site within the body, with that desired site being as dry as possible. Before placing SEPRAFILM® products in the body, the site of application is thoroughly aspirated of excess fluid. The Seprafilm® products are kept in their package until immediately before use. In one form, for example, the film measures 5 inches by 6 inches, though it can also be cut with scissors to achieve a desired size and shape. When applying, the surgeon should avoid contact with any tissue surfaces until directly at the site of application. The package insert further indicates that if contact does occur, moderate application of standard irrigation solution is used to gently dislodge the film from the unintended tissue surface. Once at the proper site of application, the biomaterial is adhered to the tissue by gently pressing the biomaterial down with a dry glove or instrument. The biomaterial remains at the site of application until it dissolves into a gel. See, e.g., U.S. Pat. No. 7,144,588. During actual usage in the operating room, SEPRAFILM® products are very delicate and cannot be handled directly without risk of crumbling. Surgeons therefore handle it as little as possible. They leave the Seprafilm sandwiched between the enclosed sheets, which do not appear to be radio opaque, while adjusting the Seprafilm sheet onto the tissue. The paper is then removed one at a time to allow the film to adhere to the tissues. If the paper gets too wet or if the film shifts during removal of the paper, the film tends to form into a gel like ball. If the film adheres to unintended tissue, it tears upon removal and must be discarded. In addition, the SEPRAFILM® products must remain relatively flat; it crumbles if attempt is made to roll or fold it to fit down a tr-haf trocar or through a small incision.
The use of adhesion barriers can be challenging because the material is usually brittle and cracks and flakes while being handled. It then becomes difficult for the physician to deliver the adhesion barrier material to the surgical site, and piece together an effective barrier from the bits and pieces of material. The instructions for SEPRAFILM® products specifically instruct that the material be “stored at 2-30° C.” SEPRAFILM® products are packed in a Tyvek®1 holder within a plastic sleeve and packed in an outer, sealed, foil pouch. The instructions state when pouch is opened the plastic sleeve should be placed “on a dry, sterile field,” and that the membrane should be kept “dry in the holder prior to application.”